In achieving IUO, the learners regularly develop three main phrasal patterns, expanding (a) to (A), (B), and (c) to (C) as follows:
Up to and including IUO, learners' utterances are S-finite but show no trace of M-finiteness.
The adverbial and discourse-organizational means for expressing temporality are already present in NUO but are enriched at IUO by the fact that the verb-argument structure allows the consistent expression of inherent lexical aspect (Aktionsart).
At IUO, the negator is placed immediately before the verb and the structure Neg + V is added to the informants' repertoire.
The "transition" from IUO (Tables 3-5, lines c-d; Tables 6-7, line c), to FUO (lines f) can thus be traced in the intervening lines.
Nevertheless, the laboratory community is right to be concerned about the guidance document statement that manufacturers should not sell RUO or IUO reagents "to laboratories that they know use the product for clinical diagnostics use.
Several potential problems are associated with the use of RUO and IUO reagents in clinical laboratory testing: (a) the creation of an uneven playing field for manufacturers; (b) the perception that manufacturers or laboratories are defying FDA regulatory authority; and (c) the reporting of inaccurate, misleading, or inconsistent results, either within a laboratory or among several laboratories.
That situation could arise, for example, if an RUO or IUO reagent is not what the vendor says it is or performs in a manner that both is inconsistent with what the vendor states and is unexpected by the clinical laboratory.
There are substantial numbers of important laboratory-developed tests for which onlyRUO and IUO reagents are currently available.
In our laboratory, the hs-cTnI IUO assay LoB was determined to be <0.
Analytically, this newer version of the hs-cTnI assay (hs-cTnI IUO) appears to have retained attributes similar to those of the prototype assay, although the estimates for both the LoB and LoD are slightly different (example, hs-cTnI IUO assay LoD = 3 ng/L compared to prototype LoD = 2 ng/L).
4] Nonstandard abbreviations: MI, myocardial infarction; ACS, acute coronary syndrome; CVD, cardiovascular disease; hs-cTnT, high-sensitivity cardiac troponin T; IUO, investigational-use-only; cTnI, cardiac troponin I; HOPE, Heart Outcomes Prevention Evaluation; PVD, peripheral vascular disease; CRP, C-reactive protein; NT-proBNP, N-terminal pro-B-type natriuretic peptide; LoB, limit of the blank; LoD, limit of detection; AUC, area under the curve; HR, hazard ratio; PEACE, Prevention of Events with Angiotensin-Converting Enzyme Inhibition.